Ferinject ferric carboxymaltose: Phase IV data

The 52-week, double-blind, international Phase IV CONFIRM-HF trial in 304 stable ambulatory symptomatic patients with CHF and iron deficiency showed that IV Ferinject met the primary endpoint of improving 6MWT distance from baseline to week 24 vs. placebo (placebo-adjusted difference of 33 m, p=0.002). Additionally, the improvement in 6MWT distance with Ferinject was maintained at week 52 vs. placebo (placebo-adjusted difference of 36 m, p<0.001). Ferinject also met the secondary endpoints of improving NYHA class, PGA score, QOL and fatigue score from baseline to week 24 onwards vs. placebo. Furthermore, Ferinject significantly reduced the risk of hospitalization for worsening HF vs. placebo (HR=0.39, 95% CI: 0.19, 0.82, p=0.009). Data were presented at the European Society of Cardiology meeting in Barcelona and published in the European Heart Journal. ...